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Sansure Biotech Inc.

China·CN-MF-000011392

Last updated September 17, 2026

Information

Country
China
Address
No.680, Lusong Road, Yuelu District, Changsha, Hunan Province, China
LinkedIn
—
Facebook
—
Phone
+86-731-88883176-6116
PRRC Contact
Ren Xiaomei
EUDAMED SRN
CN-MF-000011392
FDA FEI Number
3016619649
DUNS Number
—

Catalogue (894)

Page 5 of 18
DeviceModel / ReferenceRegistriesClassStatus
Candida Albicans, Acinetobacter Baumannii and Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3141E-24
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1006E-25
EUDAMED
Class AActive
Bacterial Vaginosis Pathogen Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3266E-24
EUDAMED
IVD GeneralActive
Dengue Fever Virus General-type Diagnostic Kit (PCR-Fluorescence Probing) S3060E
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit S10016E-64-T
EUDAMED
Class AActive
Influenza A/B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing) S3082E
EUDAMED
IVD GeneralActive
Reverse Triiodothyronine Chemiluminescence Immunoassay Kit S2149E-50
EUDAMED
IVD GeneralActive
Neisseria Meningitidis Serogroup A, B, and C nucleic acid Diagnostic Kit(PCR-Fluorescence Probing) S3263E-24
EUDAMED
IVD GeneralActive
Streptococcus Pneumoniae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3078E
EUDAMED
IVD GeneralActive
Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit S2048E-150
EUDAMED
IVD GeneralActive
Giardia Lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3233E-48
EUDAMED
IVD GeneralActive
Neutrophil Gelatinase-associated Lipocalin Chemiluminescence Immunoassay Kit S2157E-150
EUDAMED
IVD GeneralActive
SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3340E-24
EUDAMED
IVD GeneralActive
Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay) S3358E-5
EUDAMED
IVD GeneralActive
Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3056E-24
EUDAMED
Class CActive
Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay) S3356E-1
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit S10016E-96
EUDAMED
Class AActive
Rabies Virus RNA Nucleic Acid Diagnostic Kit ( PCR-Fluorescence Probing ) S3193E-24
EUDAMED
IVD GeneralActive
Insulin-Like Growth Factor-Ⅰ Chemiluminescence Immunoassay Kit S2032E-75
EUDAMED
IVD GeneralActive
Carbohydrate antigen 19-9 Assay Kit (Chemiluminescent Immunoassay) S2107E-24
EUDAMED
IVD GeneralActive
Norovirus GI/GII/Rotavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3222E-48
EUDAMED
IVD GeneralActive
Varicella-zoster virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3090E
EUDAMED
IVD GeneralActive
Pepsinogen II Assay Kit (Chemiluminescent Immunoassay) S2114E-24
EUDAMED
IVD GeneralActive
MBGV/RVFV/CHIKV Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3169E-48
EUDAMED
IVD GeneralActive
Myoglobin Chemiluminescence Immunoassay Kit S2041E-100
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit S10018E-64A-N8
EUDAMED
Class AActive
Interleukin-6 Chemiluminescence Immunoassay Kit S2035E-100
EUDAMED
IVD GeneralActive
Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit S2067E-100
EUDAMED
IVD GeneralActive
Zika Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3182E-24
EUDAMED
IVD GeneralActive
SARS-CoV-2 S-RBD Antibody ELISA Assay Kit S3273E-96
EUDAMED
IVD GeneralActive
Coxsachievirus A6 and A10 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3203E-24
EUDAMED
IVD GeneralActive
Adrenocorticotropic Hormone Chemiluminescence Immunoassay Kit S2129E-50
EUDAMED
IVD GeneralActive
Red Blood Cell Folate Chemiluminescence Immunoassay Kit S2138E-150
EUDAMED
IVD GeneralActive
Progesterone Chemiluminescence Immunoassay Kit S2051E-25
EUDAMED
IVD GeneralActive
Growth STimulation expressed gene 2 Assay Kit (Chemiluminescent Immunoassay) S2078E-48
EUDAMED
IVD GeneralActive
Brain Natriuretic Peptide Assay Kit (Chemiluminescent Immunoassay) S2075E-48
EUDAMED
IVD GeneralActive
Neuron-specific enolase Assay Kit (Chemiluminescent Immunoassay) S2110E-48
EUDAMED
IVD GeneralActive
Autoantibody against Thyroid peroxidase Assay Kit (Chemiluminescent Immunoassay) S2099E-24
EUDAMED
IVD GeneralActive
Free Triiodothyronine Chemiluminescence Immunoassay Kit S2021E-200
EUDAMED
IVD GeneralActive
Glycated Hemoglobin Chemiluminescence Immunoassay Kit S2023E-200
EUDAMED
IVD GeneralActive
Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemiluminescence Immunoassay Kit S2064E-50
EUDAMED
IVD GeneralActive
Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3117E-48
EUDAMED
IVD GeneralActive
Carcinoembryonic Antigen Chemiluminescence Immunoassay Kit S2011E-50
EUDAMED
IVD GeneralActive
Babesia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3194E-24
EUDAMED
IVD GeneralActive
Candida Albicans, Acinetobacter Baumannii and Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3141E-48
EUDAMED
IVD GeneralActive
Pregnancy-associated plasma protein-A Assay Kit (Chemiluminescent Immunoassay) S2093E-48
EUDAMED
IVD GeneralActive
SARS-CoV-2 P681R Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3158E-24
EUDAMED
IVD GeneralActive
SARS-CoV-2 Nucleocapsid Protein/Spike Glycoprotein Antibody Rapid Test (Colloidal Gold Method) S3215E-25
EUDAMED
IVD GeneralActive
Toxigenic Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing) S3350E-12-P
EUDAMED
IVD GeneralActive
25-Hydroxy Vitamin D Assay Kit (Chemiluminescent Immunoassay) S2127E-48
EUDAMED
IVD GeneralActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Sansure Biotech Inc. US